Randomized, double-blind, placebo-controlled trial to evaluate the effect of Helicobacter pylori eradication on glucose homeostasis in type 2 diabetic patients

• Published in: Nutrition, metabolism, and cardiovascular diseases Vol. 26; no. 10; pp. 893 - 898
• Main Authors: Bonfigli, A.R., Dr, Boemi, M, Festa, R, Bonazzi, P, Brandoni, G, Spazzafumo, L, Olivieri, F, Ceriello, A, Genovese, S, Testa, R
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01-10-2016
• Subjects: Aged; Amoxicillin - administration & dosage; Amoxicillin - adverse effects; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Biomarkers - blood; Blood Glucose - metabolism; Cardiovascular; Clarithromycin - administration & dosage; Clarithromycin - adverse effects; Diabetes mellitus type 2; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - diagnosis; Diabetes Mellitus, Type 2 - microbiology; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Esomeprazole - administration & dosage; Esomeprazole - adverse effects; Female; Helicobacter Infections - blood; Helicobacter Infections - diagnosis; Helicobacter Infections - drug therapy; Helicobacter Infections - microbiology; Helicobacter pylori; Helicobacter pylori - drug effects; Helicobacter pylori - pathogenicity; Homeostasis; Host-Pathogen Interactions; Humans; Inflammation; Inflammation Mediators - blood; Insulin - blood; Insulin Resistance; Italy; Male; Middle Aged; Proton Pump Inhibitors - administration & dosage; Proton Pump Inhibitors - adverse effects; Randomized clinical trial; Time Factors; Treatment Outcome; helicobacter pylori; randomized clinical trial; diabetes mellitus type 2; inflammation; insulin resistance; Insulin resistance; Inflammation; Randomized clinical trial; Helicobacter pylori; Diabetes mellitus type 2
• ISSN: 0939-4753; 1590-3729
• DOI: 10.1016/j.numecd.2016.06.012

Abstract Background and aims Literature data suggest an association between Helicobacter pylori infection and glucose homeostasis. However, a causative link between them has not been demonstrated yet. The aim of this study is to investigate the effect of Helicobacter pylori eradication on glucose homeostasis in patients with type 2 diabetes. Methods and Results A randomized, double-blind, placebo-controlled trial was conducted to investigate the effect of Helicobacter pylori eradication on glucose homeostasis in 154 patients with type 2 diabetes and who tested positive for Helicobacter pylori infection (mean age (SD), 63.1 (8.1) years). Subjects were assigned to Helicobacter pylori eradication treatment or placebo. Metabolic and inflammatory parameters were measured in all subjects at baseline and 4 weeks after the treatment. Helicobacter pylori eradication led to an improvement in glucose homeostasis, measured by HOMA-IR (p<0.001) and KITT (0=0.041), due to the decrease in fasting insulin levels (p=0.004). The results also showed that lower levels of inflammatory parameters were present after eradication. Conclusion To our knowledge this is the first randomized, double blind, controlled study where the effect of Helicobacter pylori eradication on glucose homeostasis in subjects with type 2 diabetes has been investigated. Our findings demonstrate that Helicobacter pylori eradication improves glucose homeostasis in patients with type 2 diabetes through a decrease in pro-inflammatory factors. Trial registration number: ACTRN12609000255280 ( https://www.anzctr.org.au/ )